GlaxoSmithKline is not planning to exit the U.K. just because the U.K. is exiting the European Union. As if to emphasize its commitment, the drugmaker today…

A Genzyme manufacturing site in Ireland is getting a new name, some new products and more than three dozen new jobs.

Just days after Valeant Pharmaceuticals' plans for a new eye drug were upended by a complete response letter (CRL) tied to its manufacturing operations,…

With the vast majority of drugs and drug ingredients being manufactured outside the U.S., the FDA has had to step up its international oversight and often ban…

A drug repackager that specializes in single-dose repackaging has found itself in trouble with the FDA, which issued it a warning letter for both manufacturing…

Noven has been recalling tens of thousands of boxes of its Daytrana patches from the market because of issues over peeling away a protective liner to deliver…

The handwriting was on the wall for a GlaxoSmithKline API operation in the U.K. when the drugmaker recalled more than 425,000 Bactroban antibiotic products…

Pfizer’s biologics manufacturing plant in Dublin is one of the largest in the world but will get bigger yet as the drugmaker expands the facility, in part, to…

Canada’s Apotex is perhaps the largest generic drug producer in North America and as such ships large quantities of product to the U.S., meaning its recalls…